YY 0600.2-2007 PDF English
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Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 2: Home care ventilators for ventilator-dependent patients
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YY 0600.2-2007: Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 2: Home care ventilators for ventilator-dependent patients
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YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
C 46
Lung ventilators for medical use - Particular requirements
for basic safety and essential performance - Part 2: Home-
care ventilators for ventilator-dependent patients
(ISO 10651-2:2004, MOD)
ISSUED ON: JANUARY 31, 2007
IMPLEMENTED ON: FEBRUARY 01, 2008
Issued by: China Food and Drug Administration
3. No action is required - Full-copy of this standard will be automatically &
immediately delivered to your EMAIL address in 0~60 minutes.
Table of Contents
Foreword ... 5
Introduction ... 7
1 Scope ... 9
1.101 Normative references ... 9
2 Terms and definitions ... 11
3 General requirements ... 13
4 General requirements for tests ... 13
5 Classification ... 13
6 Identification, marking and documents ... 14
7 Power input ... 19
8 Basic safety categories ... 20
9 Removable protective means ... 20
10 Environmental conditions ... 20
11 Not used ... 21
12 Not used ... 21
13 General... 21
14 Requirements related to classification ... 21
15 Limitation of voltage and/or energy ... 21
16 Enclosures and protective covers ... 21
17 Separation ... 22
18 Protective earthing, functional earthing and potential equalization ... 22
19 Continuous leakage currents and patient auxiliary currents ... 22
20 Dielectric strength ... 22
21 Mechanical strength ... 22
22 Moving parts ... 22
23 Surfaces, corners and edges ... 23
24 Stability in normal use ... 23
25 Expelled parts ... 23
26 Vibration and noise ... 23
27 Pneumatic and hydraulic power ... 23
28 Suspended masses ... 23
29 X-ray radiation ... 23
30 α, β, γ, neutron radiation and other particle radiation ... 23
31 Microwave radiation ... 24
32 Light radiation (including lasers) ... 24
33 Infra-red radiation ... 24
34 Ultra-violet radiation ... 24
35 Acoustical energy (including ultrasonic) ... 24
36 Electromagnetic compatibility ... 24
37 Locations and basic requirements ... 24
38 Marking, accompanying documents ... 24
39 Common requirements for category AP and category APG equipment . 25
40 Requirements and tests for category AP equipment, parts and components
thereof ... 25
41 Requirements and tests for category APG equipment, parts and
components thereof ... 25
42 Excessive temperature ... 25
43 Fire prevention ... 25
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization, disinfection and compatibility ... 26
45 Pressure vessels and parts subject to pressure ... 27
46 Human errors ... 28
47 Electrostatic charges ... 28
48 Biocompatibility ... 28
49 Interruption of the power supply ... 28
50 Accuracy of the operating data ... 29
51 Protection against hazardous output ... 29
52 Abnormal operation and fault conditions ... 33
53 Environmental tests ... 34
54 General... 34
55 Enclosures and covers ... 34
56 Components and general assembly ... 34
57 Mains parts, components and layout ... 37
58 Protective earthing - Terminals and connections ... 38
59 Construction and layout ... 38
101 Alarm systems ... 38
102 Appendix of general standard ... 39
Appendix AA (Informative) Rationale ... 40
References ... 46
Figure 101 -- Configuration of test apparatus for measurement of
expiratory pressure and volume ... 31
Table 101 -- Conditions for expiratory pressure and volume
measurements ... 31
Foreword
YY 0600 “Lung ventilators for medical use - Particular requirements for basic
safety and essential performance” consists of the following components:
- Part 1: Home-care ventilatory support devices;
- Part 2: Home care ventilators for ventilator-dependent patients;
- Part 3: Emergency and transport ventilators.
The following parts of YY 0600 are under preparation:
- Part 4: Operator-powered resuscitators;
- Part 5: Gas-powered emergency resuscitators.
This part is part 2 of YY 0600, which modifies and adopts the international
standard ISO 10651-2:2004 “Lung ventilators for medical use - Particular
requirements for basic safety and essential performance - Part 2: Home-care
ventilators for ventilator-dependent patients”. The main differences between
this part and ISO 10651-2:2004 are as follows:
- In this part, adjust the clause 2 “Normative references” of ISO 10651-2:2004
into 1.101; adjust the clause 3 “Terms and definitions” into clause 2, in order
to keep consistency with the number of general standard;
- In clause 46, it is modified into “not used”;
- In 56.3 bb), modify the connector of the high-pressure input port to comply
with the provisions of Table 2 and Figure 3 of ISO 5359;
- DELETE the Appendix BB;
- The unit “hPa” in this part is converted to “kPa”.
This part is a particular standard based on GB 9706.1-2007 (IEC 60601-1:1988
+ Amd1:1991 + Amd2:1995, IDT) “Medical electrical equipment - Part 1:
General requirements for safety”, which is used in conjunction with GB 9706.1
AND implemented at the same time with GB 9706.1-2007 (IEC 60601-1:1988
+ Amd1:1991 + Amd2:1995, IDT).
The clause 36 of this part is implemented at the same time with YY 0505-2005
“Medical electrical equipment - Part 1-2: General requirements for safety -
Collateral standards: Electromagnetic compatibility - Requirements and tests”.
Lung ventilators for medical use - Particular requirements
for basic safety and essential performance - Part 2: Home-
care ventilators for ventilator-dependent patients
1 Scope
GB 9706.1-2007, clause 1 applies, except as follows.
Modification:
This part of YY 0600 specifies the requirements for lung ventilators intended for
home applications for those patients who are dependent on ventilatory support.
Such ventilators are considered life-supporting equipment, are frequently used
in locations where driving power is not reliable, and are often supervised by
non-healthcare personnel with different levels of training.
This part of YY 0600 is not applicable to cuirass and “iron-lung” ventilators.
This part of YY 0600 is not applicable to ventilators intended only to augment
the ventilation of spontaneously breathing patients.
The requirements of this part of YY 0600 which replace or modify the
requirements of the general standards are intended to take precedence over
the corresponding general requirements.
1.101 Normative references
The provisions in following documents become the provisions of this part
through reference in this part of YY 0600. For the dated references, the
subsequent amendments (excluding corrections) or revisions do not apply to
this Standard; however, parties who reach an agreement based on this
Standard are encouraged to study if the latest versions of these documents are
applicable. For undated references, the latest edition of the referenced
document applies.
GB/T 4999-2003 Anesthetic and respiratory equipment - Vocabulary (ISO
4135:2001, IDT)
GB/T 5332-1985 Method of test for ignition temperature of flammable liquids
and gases (eqv IEC 60079-4:1975)
ISO 9919 Medical electrical equipment - Particular requirements for the
basic safety and essential performance of pulse oximeter equipment for
medical use
ISO 15001 Anesthetic and respiratory equipment - Compatibility with oxygen
ISO 21647 Medical electrical equipment - Particular requirements for the
basic safety and essential performance of respiratory gas monitors
IEC 60601-1-8:2003 Medical electrical equipment - Part 1-8: General
requirements for safety - Collateral standard: Alarm systems - Requirements,
tests and guidelines - General requirements and guidelines for alarm
systems in medical electrical equipment and medical electrical systems
2 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T
4999-2003, GB 9706.1, IEC 60601-1-8 AND the following terms and definitions
apply to this part of YY 0600.
Addition:
2.101
Airway pressure
Pressure at the patient connection port.
2.102
Applied part
Part of the equipment which is in normal use
- Necessarily comes into physical contact with the patient for the equipment
to perform its function, or
- Can be brought into contact with the patient, or
- Needs to be touched by the patient, or
- All parts of the ventilator intended to be connected to the ventilator
breathing system.
Note: Adapted from GB 9706.1-2007, 2.1.5.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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